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Cardiomyopathy, Hypertrophic clinical trials

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NCT ID: NCT06461468 Not yet recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Federated Learning Implementation Platform

HCM FLIP
Start date: June 2024
Phase:
Study type: Observational

HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.

NCT ID: NCT06433050 Not yet recruiting - Clinical trials for Hypertrophic Cardiomyopathy Without Obstruction

Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy

SOTA-CROSS HCM
Start date: September 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are: 1. Will sotagliflozin be well tolerated in patients with nonobstructive HCM? 2. Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM? 3. Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM? Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM). Participants will: Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks. Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.

NCT ID: NCT06412666 Not yet recruiting - Pediatric Clinical Trials

A Study to Evaluate the Effect of Aficamten in Pediatric Patients (Age 12 to <18 Years) With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).

CEDAR-HCM
Start date: May 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

NCT ID: NCT06368037 Not yet recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy

Start date: August 2024
Phase: N/A
Study type: Interventional

This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively.

NCT ID: NCT06338202 Not yet recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Real-World Effectiveness of Mavacamten in Canada

MAVEN
Start date: April 1, 2024
Phase:
Study type: Observational

The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.

NCT ID: NCT06269640 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study

Start date: June 26, 2024
Phase: N/A
Study type: Interventional

Background: Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO. Objective: To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME). Eligibility: Adults aged 21 years with LVOTO. Design: Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life. Participants will stay in the hospital 2 to 6 days for the SESAME procedure. They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart. Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum. Participants will have 3 follow-up visits within 1 year....

NCT ID: NCT06210607 Not yet recruiting - Clinical trials for Hypertrophic Cardiomyopathy

A Trial of HS-10511 in Healthy Subjects

Start date: January 31, 2024
Phase: Phase 1
Study type: Interventional

This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects.

NCT ID: NCT06146660 Not yet recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Start date: June 30, 2024
Phase:
Study type: Observational

The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

NCT ID: NCT06023186 Not yet recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM

MavaPET
Start date: September 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to measure the effect of mavacamten treatment on blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic cardiomyopathy. The main question it aims to answer is: • Does mavacamten treatment improve blood flow in the heart muscle? Participants will take mavacamten at the direction of their treating physician. Participants will complete 2 myocardial Positron Emission Tomography and Computed Tomography (PET-CT) scans. The first scan will be completed before participants start taking mavacamten. The scan will be repeated after 12 months of mavacamten treatment.

NCT ID: NCT05025644 Not yet recruiting - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test

Start date: March 2023
Phase: Phase 4
Study type: Interventional

The objectives of this study are to determine if the left ventricle outflow tract (LVOT) gradients may be reproduced with dobutamine (DBT) provocation test in obstructive HCM patients under general anesthesia and to analyze the change in anatomic LVOT area and pressure gradients (PG) before and after septal myectomy. If the DBT stress test can reproduce preoperative gradients in HCM patients during septal myectomy surgery, surgeons will have the opportunity to assess the quality of the surgical procedure depending on the obtained gradients with DBT stress test after surgery when gradients can't be reproduced during general anesthesia after myectomy, and decide if further myectomy is required, saving a re-operation on the patient in the future.